Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— SWARM-Pa  

Official title:

A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects With Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (Pa) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596319
• Other study ID #: AP-PA02-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 22, 2020
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2024
• Source: Armata Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered by inhalation in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection.

Description:

The study consists of two parts. Subjects with Cystic Fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection will be enrolled in either Part 1 (single-ascending dose cohorts) or Part 2 (multiple-ascending dose cohorts).

Part 1 will evaluate single doses of AP-PA02 at two ascending dose levels, administered by inhalation. Treatment assignment will be randomized, double-blind, placebo-controlled in each of two ascending dose cohorts. Part 2 will also be double-blinded, randomized, placebo controlled, and will evaluate the safety and efficacy of multiple doses of AP-PA02 in each of two ascending dose level cohorts.

Subjects in both Parts 1 and 2 will be followed for approximately 4 weeks and evaluated for safety, tolerability, phage titer profile and immunogenicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• = 18 years old

• Body mass index (BMI) of = 18 kg/m2

• Documented diagnosis of CF

• Evidence of chronic pulmonary Pseudomonas aeruginosa infection

• Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)

• For SAD: FEV1 = 60% of predicted normal [per Global Lung Function Initiative (GLI) standards] at Screening

• For MAD: FEV1 = 40% of predicted normal [per Global Lung Function Initiative (GLI) standards] at Screening

• Adequate renal function

Key Exclusion Criteria:

• Recent significant weight loss

• Abnormal vital signs at Screening

• History of prolonged QT syndrome

• Use of supplemental oxygen during the day at rest

• Abnormal liver function tests greater than 3X the upper limit of normal (ULN)

• Recent oral or IV antibiotics received for acute pulmonary exacerbation. Inhaled antibiotic use for chronic suppression of P. aeruginosa is acceptable.

• Recent clinically significant infection requiring systemic antimicrobial therapy

• Currently receiving anti-pseudomonal antibiotic treatment for acute sinusitis.

• Currently receiving systemic corticosteroids

• Currently receiving treatment for active infection with nontuberculous mycobacteria (NTM), Staphylococcus aureus, or Burkholderia cepacia complex lung infection

• Currently receiving treatment for aspergillosis or ABPA (allergic bronchopulmonary aspergillosis)

• Initiation of a CFTR potentiator/corrector therapy, such as Trikafta®, less than 90 days prior to Screening

• Acquired or primary immunodeficiency syndromes

• Active pulmonary malignancy (primary or metastatic)

• History of lung transplantation

• Recent hemoptysis

• Female pregnant or breastfeeding

• Heavy smoker

Related Conditions & MeSH terms

• Communicable Diseases
• Cystic Fibrosis
• Fibrosis
• Infections
• Lung Infection
• Lung Infection Pseudomonal
• Pseudomonas
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

Biological:
• AP-PA02
Bacteriophage administered via inhalation

Other:
• Placebo
Inactive Placebo administered via inhalation

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	St. Luke's Cystic Fibrosis Center of Idaho	Boise	Idaho
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Harper University Hospital	Detroit	Michigan
United States	University of Iowa	Iowa City	Iowa
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Washington	Seattle	Washington
United States	University of South Florida	Tampa	Florida
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
Armata Pharmaceuticals, Inc.	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity Treatment Emergent Adverse Events (TEAEs)	Incidence and severity of treatment emergent adverse events of single and multiple doses of AP-PA02 administered by inhalation	Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose.

External Links

•   Armata Pharmaceuticals, Inc.